Study for the Use of Alteplase in Patients Who Awaken With Stroke

Ischemic Stroke Clinical Trial

— AWOKE  

Official title:

Alteplase for Waking Onset STROKE

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01150266
• Other study ID #: AWOKE
• Secondary ID: 5P50NS044148
• Status: Withdrawn
• Phase: Phase 1
• First received: June 23, 2010
• Last updated: September 11, 2013
• Start date: August 2011

Study information

• Verified date: September 2013
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a pilot study of thrombolytic therapy in patients with ischemic stroke who present with stroke symptoms upon awakening.

Description:

Patients with ischemic stroke are currently only eligible for the treatment with intravenous thrombolysis if the stroke is diagnosed within 4.5 hours from known onset of symptoms.

Many patients awaken with stroke and are excluded from this therapy, following current guidelines.

Patients who suffer from a stroke just before or after waking up may be candidates for thrombolysis and our study will use advanced neuroimaging to select those patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Age =22

2. Stroke upon awakening

3. Measurable deficit by NIHSS

4. No deficit before sleep or last seen normal before to sleep

5. Head CT with no evidence of intracranial hemorrhage.

6. Able to receive IV t-PA treatment within 2.5 hrs after patient awoke with deficit.

7. Written informed consent signed and dated by the patient (or patient's authorized representative)

8. Core lesion: ASPECTS =7 on MRI-DWI, CTP-CBV or CTA source imaging.

9. Mismatch of at least 20% measured by CT CVB/MMT or DWI/TTP

Exclusion Criteria:

1. Stroke or serious head trauma within the preceding 3 months

2. Major surgery or serious trauma within 14 days

3. History of intracranial hemorrhage

4. Systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg that is not controlled after aggressive measures.

5. Rapidly improving or minor symptoms

6. Symptoms suggestive of subarachnoid hemorrhage.

7. Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days.

8. Arterial puncture at a non-compressible site within the previous 7 days

9. Seizure at the onset of stroke and considered the cause for the neurological symptom.

10. Patients who are taking anticoagulants or who had received heparin within the 48 hours preceding the onset of stroke and have an elevated partial-thromboplastin time, INR>1.7 or platelet counts below 100,000/mm3

11. Finger sticks glucose below 50 mg/dl (2.7 mmol/ Lt) or above 400 mg per deciliter (22.2 mmol/Lt) and considered the cause for the neurological symptom.

12. Active internal bleeding

13. Pregnancy in women of child-bearing potential (must have pregnancy test, urine or blood, prior to therapy).

14. Lumbar puncture within 7 days.

15. Known co-morbid conditions likely to complicate therapy or interfere with patient assessment, such us: heart failure stage 4, severe dementia, end-stage AIDS, pericarditis, cirrhosis or known cancer.

16. Unable to obtain CTA or perfusion brain studies (PWI or CTP)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• Alteplase (tPA)
0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Neurological Disorders and Stroke (NINDS), Scripps Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic Intracranial Hemorrhage	sICH is defined as any confluent dense hematoma occupying greater than 30% of the infarcted area with substantial space occupying effect, or any brain hemorrhage outside the infarcted area that occurs within 72 hours of tPA treatment and is associated with an increase of at least 4 points in the NIHSS.	0-72 hours	Yes
Secondary	Modified Rankin Scale	A good outcome is defined as a modified Rankin Scale (mRS) of =1 or return to baseline mRS.	90 days	No
Secondary	National Institutes of Health Stroke Scale (NIHSS)	An improvement of the NIHSS is defined as a 4-point improvement in the NIHSS, or NIHSS 0 measured 24 hours after treatment.	24 hours	No